Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

Completed · Phase 3

Conditions studied: Parenteral Nutrition Associated Cholestasis

In brief

The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders

Key facts

Study ID

NCT01555957

Run by

University of Rochester

People needed

40

Starts

2012-02-01

Expected to finish

2019-01-31

Last updated by the study team

2020-12-03

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis, omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible for this study

You may not qualify if…

• If does not need TPN by 72 hours;
• Direct hyperbilirubinemia within the first 72 hours after birth;
• TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);
• Biliary tract disorders leading to direct hyperbilirubinemia;
• Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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